Mesalazine is indicated for:

• Treatment of mild to moderately active Ulcerative Colitis & Crohn’s Disease
• Maintenance of remission in Ulcerative Colitis
• Maintenance of remission in Crohn’s Disease

The exact mechanism of action of Mesalamine is not fully known, but it is believed to act locally in the intestine rather than systemically. In chronic inflammatory bowel disease, the production of Arachidonic Acid metabolites increases through both cyclooxygenase (prostaglandins) and lipoxygenase (leukotrienes and related compounds) pathways. Mesalamine helps reduce inflammation by inhibiting cyclooxygenase activity and decreasing prostaglandin synthesis in the colon.

Tablet dose: Treatment of mild to moderate Ulcerative Colitis-

• Adult: For adults, the recommended dosage of Mesalazine is 800 mg (two 400 mg tablets) three times daily for a duration of 6 weeks. However, a dose up to 4.8 g/day in divided doses may be given if needed.
• Child: For child patients 5 years of age and older, daily dosage of Mesalazine is as follows-

Maintenance of remission of mild to moderate Ulcerative Colitis-

• Adult: The recommended dosage of Mesalazine is 1.6 g (four 400 mg tablets) daily in two to four divided doses. However, a dose up to 2.4 g/day in divided doses may be given if needed.

Maintenance of remission of Crohn's disease

• Adult: 1.2-2.4 g daily in divided dose.
• Child: 400-800 mg 3 times daily.

Prolonged release granules dose: Treatment of ulcerative colitis-

Adults:

• Active disease: Individual dosage, up to 4 gm mesalazine once daily or divided into 2-4 doses.
• Maintenance treatment: Individual dosage. Recommended dosage, 2 gm mesalazine once daily.

Pediatrics: The safety and efficacy in children below 6 years of age have not been established. There is only limited documentation for an effect in children (age 6-18 years).

Children 6 years of age and older:

• Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
• Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose).
• It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.

The granules must not be chewed. The contents of the sachet should be emptied onto the tongue and washed down with some water or orange juice. Alternatively, the entire content of the sachet can be taken with yogurt and consumed immediately.

Concomitant use of other nephrotoxic drugs such as NSAIDs and Azathioprine may increase the risk of renal adverse effects.

Hypersensitivity to salicylates or to any component of the formulation.

Commonly reported adverse effects include headache, nausea, dizziness, weakness, dyspepsia, vomiting, itching, etc.

Use during pregnancy only if the expected benefit outweighs the potential risk to the fetus. Caution should be exercised when administered to breastfeeding mothers.

Patients with pyloric stenosis may experience delayed gastric emptying of Mesalamine tablets, which can delay drug release in the colon. Renal impairment, including minimal change nephropathy and acute or chronic interstitial nephritis, has been reported. Therefore, caution is advised in patients with existing renal dysfunction or a history of kidney disease. Renal function should be assessed before starting therapy and monitored periodically during treatment. Cases of hepatic failure have been reported in patients with pre-existing liver disease receiving Mesalamine. Caution is required in patients with hepatic impairment.

Geriatrics: In patients aged 65 years and above, blood cell counts should be closely monitored during therapy.
Elderly: Since elderly patients are more likely to have reduced renal function, careful use is recommended. Renal function should be evaluated before starting treatment and blood counts monitored during therapy.
Paediatric: Safety and efficacy have not been established.

There is no specific antidote for Mesalamine overdose. Management should be symptomatic and supportive, including prevention of further gastrointestinal absorption, correction of fluid and electrolyte imbalance, and maintenance of renal function. As this is a pH-dependent delayed-release formulation, this should be considered during overdose management.

Aminosalicylates

Store below 30°C. Protect from light and moisture. Keep out of reach of children.